Kornimate/medical-research-clean huggingface dataset:
a dose-ranging study of the safety and effectiveness of mk-8237 in the treatment of house dust mite (hdm) induced allergic rhinitis/rhinoconjunctivitis in adults (mk-8237-003/p07627)

Conditions: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal

Summary: the purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of mk-8237, compared to placebo, in the treatment of house dust mite (hdm)-induced allergic rhinitis/rhinoconjunctivitis in adults. the primary hypothesis is that administration of mk-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (tnss) determined during environmental exposure chamber (eec) challenge.


Eligibility criteria:
inclusion criteria: * history of allergic rhinitis/rhinoconjunctivitis to house dust of 1 year duration or more (with or without asthma) * if female of childbearing potential, has a negative urine pregnancy test at screening and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study. exclusion criteria: * sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.) * sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen) * immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms) * history of chronic urticaria and/or angioedema within 2 years prior to screening * previous immunotherapy treatment with any hdm allergen for more than 1 month within 3 years prior to screening * ongoing treatment with any specific immunotherapy * history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen * unstable uncontrolled/partially controlled or severe asthma, or life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[saba\]) within 3 months prior to screening * asthma requiring medium- or high-dose inhaled corticosteroid (ics) within 12 months prior to screening * chronic sinusitis within 2 years prior to screening * nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps) * pregnant, breastfeeding or planning to become pregnant during the study * participation in a different investigational study at any site during the same time frame of this study * direct association with the administration of the study or a family member of the study staff
a distraction protocol for peripheral intravenous (iv) placement in the pediatric emergency department

Conditions: Pain

Summary: this is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. the study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.

routine care patients will have intravenous lines placed in the usual manner. intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.

Eligibility criteria:
inclusion criteria: * ages 4 - 9 * requiring iv placement for medical care in emergency department * child cognitively normal exclusion criteria: * no significant chronic medical conditions * no iv in past 3 years

Keywords: pain associated with peripheral intravenous line placement
pre and post-arterial recanalization imaging of central retinal artery occlusions (crao)

Conditions: Retinal Artery Occlusion; Magnetic Resonance Imaging; Diagnosis; Etiology; Prognosis

Summary: central retinal artery occlusions (crao) are the equivalent of an ischemic stroke at the retinal level. they share the same risk factors and common pathology. the diagnosis of a crao is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. small studies have highlighted the value of cerebral mri (magnetic resonance imaging) in crao with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). but there are usually few radiological signs that allow a direct positive diagnosis of crao, an etiologic diagnosis or a prognosis. this descriptive study will focus on crao at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of crao with specific sequences from a 3 tesla mri, (ii) identify positive diagnostic signs of crao with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the crao.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * crao (onset of symptoms ≤ 48 hours) * consent to participate in the study exclusion criteria: - contraindications to 3 tesla mri
the most frequently preferred surgical method in the treatment of sacrococcygeal pilonidal disease

Conditions: Pilonidal Sinus

Summary: there is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (spd). the study aimed to retrospectively screen the cases that had undergone surgical treatment for spd in the last 15 years in four different tertiary stage hospitals and analyze the most frequently used surgical treatment method and its results.

the researchers in our study will retrospectively scan the records of patients who have been operated on for spd in the last 15 years at health sciences university konya health practice and research center, selçuk university medical faculty hospital, necmettin erbakan university medical faculty hospital, and başkent university medical faculty hospital general surgery clinics. demographic characteristics of the patients, type of anesthesia, duration of operation, duration of hospitalization, time to return to work or school, final healing time, follow-up time, and recurrence information will be transferred to the spss statistics program analyzed. the researchers could not find any articles in the literature on the subject. therefore, this study will contribute to the literature.

Eligibility criteria:
inclusion criteria: * all patients between the ages of 14-80 who underwent surgery for pilonidal sinus exclusion criteria: * unregulated diabetes mellitus * collagen tissue disease * decompensated cardiovascular disease * cases with missing follow-up information

Keywords: pilonidal surgery healing
valved graft pmcf study

Conditions: Aortic Valve Disease; Ascending Aorta Abnormality; Aortic Dissection

Summary: multicenter, global, prospective, non-randomized, interventional, post-market trial. all subjects enrolled will receive an abbott valved graft device.


Eligibility criteria:
inclusion criteria: * cardiac surgery including the implant of a vavgj or cavgj for native or prosthetic valve replacement exclusion criteria: * anticoagulation therapy intolerant * active endocarditis * anatomical or medical, surgical, psychological or social contraindications

Keywords: aortic root replacement ascending aorta replacement valved graft cavgj vavgj
sing for your saunter - dementia supplement

Conditions: Parkinson Disease; Parkinson Disease Dementia

Summary: older adults, and particularly those with parkinson disease (pd), may experience walking difficulties that negatively impact their daily function and quality of life. people that have pd plus dementia are also likely to experience walking difficulties. this project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are most helpful. pilot work from the investigators suggests that imagined, mental singing (i.e., singing in head) while while walking helps people walk faster with greater stability, whereas walking to music also helps people walk faster but with reduced stability. in this study, the investigators will recruit people who have pd plus dementia. the investigators will compare walking while mentally singing and walking while listening to music, using personalized cues tailored to each person's walking performance. the investigators hypothesize temporal variability of gait will be lower in the mental singing and singing conditions compared to listening to music; and that mental singing, singing, and listening to music will elicit similar improvements in stride length.

during this observational study, participants will attend one visit in the laboratory. the visit will include participants wearing wearable sensors during the following tasks: walking with no cues (uncued), walking while listening to music (music), and walking while mentally singing (mental singing). the wearable sensors will measure gait parameters including gait speed, stride length, and stride time variability.

Eligibility criteria:
inclusion criteria: * at least 30 years of age * diagnosis of idiopathic, typical parkinson disease according to the uk brain bank criteria * hoehn \& yahr stages 2-3 (mild to moderate disease severity) * normal or corrected hearing * stable on all pd medications for at least 2 months prior to study entry * dementia as defined by a clinical dementia rating (cdr) score of 0.5-1.0 (very mild to mild dementia) * score of ≥ 1 on the mds-updrs-iii item #10 indicating observable gait impairment * a score of 1 or less on item #7 on the freezing of gait questionnaire * able to walk for 10 continuous minutes independently exclusion criteria: * diagnosis of any other neurological condition * unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation * cardiac problems that interfere with ability to safely participate (i.e., uncontrolled congestive heart failure, myocardial infarction in past 6 months, complex cardiac arrhythmias, significant left ventricular dysfunction, dyspnea on exertion, chest pain or pressure, resting tachycardia (\>100 beats/min); uncontrolled bp (resting systolic bp \>160 mmhg or diastolic bp \>100 mmhg)) * orthopedic problems in the lower extremities or spine that may limit walking (i.e., severe arthritis, spinal stenosis) * uncontrolled tremor or dyskinesia while on pd medications

Keywords: parkinson disease music mental singing gait
efficacy of transcutaneous versus percutaneous posterior tibial nerve stimulation in the overactive bladder.

Conditions: Overactive Bladder Syndrome

Summary: the main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.

overactive bladder syndrome (oab) is a set of symptoms characterized by urge, with or without urge incontinence, usually with frequency and nocturia in the absence of urinary infection or other pathologies. oab affect considerably the quality of life of the subject who suffer. the first line of treatment is a conservative management as behavioral interventions, followed by pharmacological management as antimuscarinic or antimuscarinic drugs. percutaneous tibial nerve stimulation (ptns) is present as another alternative of treatment. previous studies have shown the positive effects of ptns in a reduction on oab symptoms. the ptns was described by stoller in 1999. it's a electrical stimulation of the tibial nerve, inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia, to stimulation of the sacral segments s2 and s3, where the spinal centre of bladder is located. the parameters used are 20hz and 200 µs, 12 sessions, two weekly, 30 min treatment. the ptns is a minimal invasive technique, but can be utilized surface electrodes instead of needle to minimize the discomfort of prick. the main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.

Eligibility criteria:
inclusion criteria: * subjects diagnosis of overactive bladder * subjects refractory to treatments antimuscarinic or beta 3-agonist * subjects who do not take restricted medication * subjects who can cognitively complete the voiding diary and questionnaires * subject with symptoms 3 months ago * men must be discarded obstruction by benign prostatic hyperplasia exclusion criteria: * subjects with stress incontinence * subjects with urinary tract infection * subjects with neurological disease * subjects with pacemakers fitted * pregnancy * subjects who have disorder sensitive * a history of pelvic tumors * subject who is not able to understand the physiotherapist

Keywords: urgency incontinence nocturia frequency
metformin as a novel therapy for autosomal dominant polycystic kidney disease

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: this study will test to see if metformin is safe and if it is tolerated compared to placebo in adult autosomal dominant polycystic kidney disease (adpkd) patients with beginning stages of chronic kidney disease. we will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.

there is growing evidence that metformin, a drug widely used for the treatment of type 2 diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the early stages of autosomal dominant polycystic kidney disease adpkd by activating the metabolic sensor amp-activated protein kinase (ampk). ampk is activated under conditions of metabolic and other cellular stresses. through its actions on downstream mediators, ampk activation during low energy states decreases cellular energy consumption while stimulating energy generating pathways. it has been shown that ampk phosphorylates and inhibits cystic fibrosis transmembrane conductance regulator (cftr), thus suppressing epithelial fluid and electrolyte secretion. similarly, ampk phosphorylates the tuberin protein, leading to indirect inhibition of the mtor pathway. thus, ampk inhibits both cftr and mtor, suggesting that targeted activation of this kinase by metformin may provide a therapeutic benefit in adpkd. it has been shown that metformin treatment of kidney epithelial cells leads to stimulation of ampk and subsequent inhibition of both mtor and cftr activity. it has also been shown that metformin slows cystogenesis in animal models of pkd, supporting the potential of this drug in adpkd treatment.

Eligibility criteria:
inclusion criteria: subject has autosomal dominant polycystic kidney disease; subject is fluent in english exclusion criteria: subject is not on active military duty; subject is not currently participating in another clinical trial; subject's current gfr is not \<50 cc/min/1.73m2; subject does not have diabetes; subject does not have a systemic disease other than hypertension and pkd; subject does not have a solitary kidney; subject does not have an allergy or intolerance to metformin; subject is not pregnant or lactating or intending to become pregnant within the next three years; subject does not have an unstable or unclipped cerebral aneurysm; subject does not have active coronary artery disease; subject does not have an mri incompatible device/implant; subject does not have severe claustrophobia; subject has not had any solid organ transplant; subject does not have a vitamin b12 deficiency; subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (jynarque or samsca)

Keywords: kidney disease polycystic kidney disease autosomal dominant kidney disease kidney cysts pkd
safety and efficacy of drug combinations against triple infections

Conditions: Parasitic Diseases

Summary: this randomised, controlled, double blinded clinical study investigates the safety and efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and soil-transmitted helminthiasis.


Eligibility criteria:
inclusion criteria: * those who will be in class one to six by the time of study * aged 5-18 years and found infected with either sch, any sth or lf for treatment groups 1,2 or 3 or infected with both sch and lf for treatment group 4 and infected with all the three for treatment group 5 * who are willing and consent and whose parents will consent, will be included in the study. exclusion criteria: * those with acute and chronic diseases other than the targeted infections and those with a history of any serious adverse drug reactions will not be included in the study. * children with total bilirubin \> 50µmol/l and alat (alanine transferase) \> 70iu/l will not qualify for recruitment.
study of bms-986158 in subjects with select advanced cancers

Conditions: Advanced Tumors

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of bms-986158 in subjects with select advanced cancers


Eligibility criteria:
inclusion criteria: * must have select advanced cancers with specific genetic profiles * must have received appropriate standard of care * at least one measurable lesion at baseline * expected to have life expectancy of at least 3 months * eastern cooperative oncology group (ecog) of 0 to 1 exclusion criteria: * concomitant second malignancies * uncontrolled or significant cardiovascular disease * inadequate bone marrow function * chronic gastrointestinal illness * prior treatment with bromodomain and extra-terminal (bet) inhibitor other protocol defined inclusion/exclusion criteria could apply
an open study to assess the robustness of the crc749 inhaler

Conditions: Asthma; COPD

Summary: to confirm the robustness of the crc749 inhaler.


Eligibility criteria:
inclusion criteria: 1. males and females at least 12 years of age. 2. a clinical diagnosis for at least 12 weeks prior to screening of asthma or copd and stable treatment. 3. spirometry following salbutamol showing fev1 ≥40% of predicted normal and fev1/fvc ratio \<0.7 for copd subjects. 4. spirometry without salbutamol showing fev1 ≥50% of predicted normal for asthma subjects. 5. ability to use the crc749 inhaler. exclusion criteria: 1. other chronic or active respiratory disorder or symptoms of, or treatment for a copd or asthma exacerbation during the 28 days preceding screening. 2. history of long qt syndrome or screening ecg with qtcf greater than 480 milliseconds. 3. current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, nyha class iii/iv left ventricular failure, or myocardial infarction. 4. subjects in whom advair(r) diskus(r) / seretide(r) accuhaler(r) are contra-indicated.

Keywords: inhaler adolescent
anti-oxidant therapy and postoperative cardiac events (ace) trial, preoperative intervention in vascular surgery

Conditions: Myocardial Injury

Summary: n terminal (nt)-pro b-type natriuretic peptide (bnp) levels provide incremental value in perioperative risk assessment prior to major non-cardiac surgery. the investigators will test whether pharmacologically lowering this biomarker with daily administration of coq10 for 3 days prior to elective vascular surgery will reduce adverse outcomes following the operation.

patients will be screened during their preoperative evaluation. inclusion criteria include patients in need of an elective vascular operation. exclusion criteria include urgent operation, known allergic reactions to coq10 and participation in another research study. suitable participants will be randomly assigned to receive either coq10 (400 mg per day) versus placebo for 3 days prior to surgery. a randomized, double blind trial will be used and a research pharmacist will guide the randomization process, blinded to clinical information. the primary end-point measures are bnp levels at 24 and 48 hours following the operation as well as the incidence of myocardial injury, defined by an elevated post-operative high-sensitivity troponin following high risk surgery. secondary outcome measures include the magnitude of the troponin level, which is the change in the level compared with preoperative baseline troponin levels and adverse clinical cardiac outcomes during the hospitalization period, including death, non-fatal myocardial infarction, diagnosed by a cardiologist who is blinded to the treatment strategy and any coronary artery revascularization procedure. the study will be focused on 30-days following the vascular procedure but the investigators may plan to extend secondary outcome measures for 1 year post-randomization.

Eligibility criteria:
inclusion criteria: * elective high risk non-cardiac surgery exclusion criteria: * reaction to coq10
characterization of the efficacy of furosemide depending on albumin function

Conditions: Acute Renal Failure; Critical Illness

Summary: during this prospective, uncontrolled and non-interventional observational study, the influence of albumin function on the efficacy of furosemide will be investigated. the aim of the study is to provide information on the efficacy of furosemide depending on albumin function.

in patients with intravenous furosemide administration, an additional 15 ml of blood is taken for the analysis of specific parameters as part of the blood sampling necessary for the treatment of the patient. the effect of furosemide is assessed on the basis of the patient's urine excretion. for this purpose, fluid intake and excretion are balanced over 6 hours. the blood sample is taken at the beginning of the balancing period. in addition, the albumin concentration, abic, as well as the total and free concentration of furosemide in the collected urine are determined.

Eligibility criteria:
inclusion criteria: * informed consent * attending intensive care physician intends to prescribe iv furosemide to increase urine output * arterial (central venous if applicable) and urinary catheter in situ exclusion criteria: * attending intensive care physician intends to prescribe further doses of diuretic medication (including furosemide infusion) within the 6 hours required for fluid collection * patients who received intravenous or oral diuretics (including mannitol) in the 6 hours prior to study enrolment * patients who have received other medications (e.g. fludrocortisone) known to affect renal sodium or water excretion in the 24 hours prior to study entry * patients with uncontrolled hyperglycaemia (plasma glucose \>10mmol/l). * patients who were receiving renal replacement therapy prior to the start of the study * patients with obstructive uropathy, macroscopic haematuria or intra-abdominal hypertension (\>20mmhg) * age \< 18 years

Keywords: furosemide albumin function albumin